Device Software Safety Risks: Standards Lead to Closer FDA Scrutiny

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Compliance with IEC 62304 is required for all electromedical devices where basic safety or essential performance depends on software or firmware.

However, many devicemakers — especially small to mid-size companies — are unaware that their devices must meet this standard.

The confusion seems to stem from the fact that the guidance is called both “voluntary” and "mandatory."

What can you do to clarify what the requirements mean to your company?

Order the new FDAnews management report:
Device Software Safety Risks
Standards Lead to Closer FDA Scrutiny

At the heart of the standard is what is called “Essential Performance” (EP).

If a piece of software impacts on the EP of a device (as defined by the standard), then it must comply by meeting or exceeding that standard.

And with the number of medical devices relying on software or firmware on the rise, more devices than ever are subject to this requirement.

Failure to comply can mean the FDA’s disapproval of the product — for both new and revised versions.

So, in this new report, you'll find best practices that will help you understand and successfully comply with IEC 62304, such as how to:

  • Identify your two biggest prospective pitfalls: documentation and software 'pedigree'
  • Understand and address 3 key noncompliance factors: software partitioning … document development … and version control (and updates)
  • Design a detailed action list that can help you correctly prepare your device for approval and marketing
  • Write a test report form that stands up to FDA scrutiny, and demonstrates clear compliance (or a defensible explanation of why the device is exempt)
  • Assess the 3 keys of successful compliance: 1) defining operational and manufacturing processes, 2) documenting and assessing operational risks, and 3) defining controls

The risks to patient safety in electromedical devices are widespread — and they are NOT always easy to discern at the manufacturing level.

For example, what would happen if the creator of a hoist didn’t properly vet the software that signaled it to lower the patient at a defined speed?

Lowering a patient too quickly — or not all — can easily become a risk management nightmare with IEC 62304 regulatory and legal implications.

Device Software Safety Risks will help you spot common scenarios that are all too easy to miss, such as:

  • Alarms and alerts are deemed an EP because they are designed to detect abnormalities. If an alarm is removed, or malfunctions, the device becomes an unacceptable risk.
  • Speed and position sensors assess basic safety concerns. For example, a hospital bed has a position sensor to keep it from crushing the operator’s foot. Mammography machines have a sensor to gauge compression. If those sensors don’t work, there’s a problem.
  • Algorithms: If the software controlling them is removed or fails to work, the device is no longer able to operate as intended. That moves the device to the EP category.

Finally, this report will ensure that you fully understand this complex requirement and what you must do to comply. It will help you learn how to secure FDA approval of your device by clearly demonstrating that its safety testing is adequate.

Device Software Safety Risks: Standards Lead to Closer FDA Scrutiny is must-read material for today's device manufacturing professionals. Order your copy NOW.

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Table of Contents

  • Introduction
  • Understanding IEC 62304
  • Complying with IEC 62304
  • Avoiding Pitfalls
  • And More …

View the entire TOC

Who Will Benefit

  • Compliance/regulatory affairs professionals
  • Managers of GMP facilities
  • Supply chain managers
  • QC and analytical methods scientists and managers
  • QA directors, managers and personnel
  • Regulatory attorneys

Meet the Authors

This report is based largely on an FDAnews webinar featuring Rita King, CEO of MethodSense. King has served as a regulator, technologist and professional auditor for more than 23 years and participated in numerous national and international committees to develop industry standards and regulations.

She is a founding member of the Underwriters Laboratories team that defined, launched, and managed the operations of the first U.S. program to evaluate safety critical software used in commercial and medical devices. She also contributed to the development of the American National Standards Institute-approved standard for safety critical software, UL 1998.

The report also is based on an FDAnews webinar featuring Jodi Scott, a partner with Washington law firm Hogan Lovells.

Scott focuses her practice on assisting the medical device industry in navigating the complex requirements for achieving U.S. marketing authorization and maintaining compliance to the FDA quality systems and other postmarket regulatory requirements.

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